NCT03451331 - Gemcitabine + Carboplatin + Nivolumab Versus Gemcitabine + Oxaliplatin + Nivolumab in Cisplatin-ineligible Patients With Metastatic Urothelial Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 10, 2018

Primary Completion Date

June 7, 2023

Study Completion Date

July 28, 2023

Conditions

Metastatic Urothelial Cancer

Interventions

DRUG

Nivolumab

Nivolumab 360mg (and/or) Maintenance Single Agent Nivolumab 480mg (starting \~ 2-4 weeks after completing combination chemotherapy plus nivolumab)

DRUG

Gemcitabine

1000 mg/m\^2

DRUG

Carboplatin

AUC 4.5 (based on the Calvert formula)

DRUG

Oxaliplatin

130 mg/m\^2

Trial Locations (6)

Icahn School of Medicine: Tisch Cancer Institute at Mount Sinai Medical Center, New York

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore

Vanderbilt-Ingram Cancer Center, Nashville

Huntsman Cancer Institute University of Utah, Salt Lake City

John Theuer Cancer Center, Hackensack

Rutgers Cancer Institute of New Jersey, New Brunswick